Samsung Bioepis receives final European approval for its Remicade copy

SEOUL South Korea’s Samsung Bioepis said on Monday its biosimilar of Johnson Johnson’s (JNJ.N) blockbuster rheumatoid arthritis drug Remicade has received final approval from European regulators, paving the way for its second product launch in Europe.

Samsung Bioepis, an unlisted arm of South Korea’s top conglomerate Samsung Group [SAGR.UL], also said last week the biosimilar had been submitted for review in the United States.

A relative latecomer to the industry, Samsung Bioepis has found early success by beating rivals to market on some of the world’s top-selling drugs. It became the first company to launch a biosimilar version of Amgen’s (AMGN.O) Enbrel, another rheumatoid arthritis drug, in Europe.

Samsung Biologics, Bioepis’ parent company, is planning an initial public offering in South Korea by the end of the year that analysts say could raise up to 3 trillion won ($2.5 billion).

Samsung Bioepis said minority shareholder and partner Biogen (BIIB.O) will be responsible for the commercialization and distribution of its Remicade copy, called Flixabi in Europe.

Biosimilars, lower-cost copies of complex biotech drugs, are still relatively new but interest is growing quickly as firms such as Bioepis launch cheaper versions of blockbuster drugs.

The Samsung Group hopes the biosimilars business will develop into a new growth driver as global demand for smartphones plateaus, weighing on the outlook for its flagship firm Samsung Electronics (005930.KS).

($1 = 1,190.0000 won)

(This version of the story corrects paragraph 2 to say Bioepis’ announcement of U.S. submission was last week, not the submission itself)

(Reporting by Se Young Lee; Editing by Edwina Gibbs)

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